A phase III trial investigating the efficacy and safety of Grazax in children aged 5-16 years with grass pollen induced rhinoconjunctivitis with or without asthma

ALK-Abello, Group Clinical Development0 个研究点开始时间: 2006年9月25日最近更新: 2012年3月19日

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•To investigate the efficacy and safety of Grazax based on the following information:
•?Rhinoconjunctivitis symptom and medication scores in the peak grass pollen season
•?Asthma symptom and medication score in the grass pollen season
•?Asthma symptom and medication score in the peak grass pollen season
•?Pharmacoeconomic data in the grass pollen season
•?Safety Assessments at screening and End of treatment
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria
•1.Current food allergies with oral allergy syndrome
•2.A clinical history of symptomatic seasonal allergic rhinitis and/or asthma having received regular medication due to another allergen during – or potentially overlapping - the grass pollen season.
•3.A clinical history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed
•4.A clinical history of chronic sinusitis during the last 2 years
•5.A clinical history of severe asthma (Step 4, according to GINA definition)
•6.Any clinical relevant chronic disease
•7.Current severe atopic dermatitis
•8.Use of an investigational drug within 30 days prior to screening
•9.Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years
•10.Use of any of the following drugs within the time indicated prior to randomisation or during the study period unless provided as rescue medication:

发起方

ALK-Abello, Group Clinical Development